Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Postoperative recall of auditory stimuli and intraoperative noise
研究概览
简要总结
Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.
详细描述
Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing total knee or total hip replacement.
- •ASA I, II, or III.
- •patients undergoing spinal anesthesia.
排除标准
- •patient refusal.
- •<24 hours sedative administration.
- •patient with hearing impairment.
- •neurological or memory disorder.
- •abnormal kidney function tests.
- •any contraindication for spinal anesthesia.
研究组 & 干预措施
Group C (control group)
control group will receive no sedation under spinal anesthesia.
干预措施: spinal anesthesia with no sedation. (Procedure)
Group O (single dose group)
patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.
干预措施: single-dose midazolam for sedation under spinal anesthesia. (Drug)
Group M (double dose group)
patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.
干预措施: Double-dose midazolam for sedation under spinal anesthesia. (Drug)
结局指标
主要结局
Postoperative recall of auditory stimuli and intraoperative noise
时间窗: 4 months
For auditory recall, a question was asked by the surgeon to the patient at maximum stimulation. Patients were examined for auditory recall by following-up the patients postoperatively in the inpatient department.
Postoperative recall of visual stimuli
时间窗: 4 months
For visual recall, a picture of a horse assigned at maximum stimulation, a cat at recovery room, and a bird after discharge to the inpatient department. Patients were examined for visual recall by following-up the patients postoperatively in the inpatient department.
次要结局
未报告次要终点
研究者
Mahmoud M. Almustafa
Principal Investigator
University of Jordan